Baclofen for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00082485

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

Detailed Description

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Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Conditions

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Cocaine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Baclofen

Intervention Type DRUG

Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Baclofen

Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject must have DSM-IV diagnosis of cocaine dependence.
* Subject must be seeking treatment for cocaine dependence.
* Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.

Exclusion Criteria

* Please contact site for more information.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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National Institute on Drug Abuse

Principal Investigators

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Liza Gorgon, M.A.

Role: PRINCIPAL_INVESTIGATOR

VA Maryland Health Care System

Locations

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San Francisco General Hosptial

San Francisco, California, United States

Site Status

Torrance Site

Torrance, California, United States

Site Status

Denver VA Medical Center

Denver, Colorado, United States

Site Status

VA Maryland Healthcare System

Baltimore, Maryland, United States

Site Status

U of Penn School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

South TX VA Health Care System

San Antonio, Texas, United States

Site Status

Salt Lake City VA Medical Center

Salt Lake City, Utah, United States

Site Status

Institute of Resch & Educ Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Countries

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United States

References

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Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.

Reference Type RESULT
PMID: 19414226 (View on PubMed)

Other Identifiers

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NIDA-CSP-1021-1

Identifier Type: -

Identifier Source: org_study_id

NCT00431938

Identifier Type: -

Identifier Source: nct_alias

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